ACUMED MODULAR SHOULDER SYSTEM— 510(k) K992525

Name: FDA 510(k) clearance K992525
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K992525 for ACUMED MODULAR SHOULDER SYSTEM, Substantially Equivalent on 2000-02-04. Applicant: Acu Med, Inc.. Device class: 2.

Clearance details

Applicant: Acu Med, Inc.
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 1999-07-28
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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K993657 — ACUMED SUTURE ANCHOR2000-01-13
K980103 — ACUMED SUTURE ANCHOR1998-03-16

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.